Biopharma Single-Use Operations Specialist | GMP-Ready

Coalesce Management Consulting; Singapore; Presencial; SGD 90.000 - 120.000; Jornada completa

Descripción de la vacante

Coalesce Management Consulting is seeking a Manufacturing Operations Specialist to provide hands-on support for single-use systems within a GMP biopharma environment. You will coordinate change controls, assist with process documentation, and ensure equipment readiness on the manufacturing floor.

The role requires five years of relevant experience and a willingness to participate in a 24/7 on-call rotation.

Formación

• Bachelor's degree in Engineering, Biotechnology, Life Sciences, or related field.
• Approximately five years of GMP-regulated biotech/pharma manufacturing experience.
• Experience supporting site-based manufacturing operations and time-sensitive shop-floor issues.
• Proven experience managing change controls from initiation to closure.
• Strong GMP documentation experience covering deviations, investigations, CAPAs, SOPs, and revisions.
• Ability to interpret process diagrams and equipment information.
• Detail-oriented with strong organisational, communication, and cross-functional skills.
• Willingness to participate in a 24/7 on-call rotation.

Responsabilidades

• Provide day-to-day operational support for single-use systems, assemblies, and consumables on the manufacturing floor.
• Set up, installation, and readiness of single-use equipment and process assemblies.
• Respond to leaks, integrity failures, and single-use defects.
• Coordinate investigations and follow-up actions with stakeholders.
• Participate in an on-call rotation in a 24/7 environment.
• Lead change controls from impact assessment to closure.
• Prepare and update SOPs, work instructions, and process diagrams.
• Support deviations, investigations, and CAPAs; maintain GMP records.
• Review single-use diagrams to confirm configurations for manufacturing use.
• Coordinate readiness and handover across multiple functions and vendors.

Conocimientos

GMP documentation

Change control management

Shop-floor troubleshooting

Cross-functional teamwork

On-call readiness

Process diagram interpretation

Attention to detail

Educación

Bachelor's degree in Engineering, Biotechnology, Life Sciences, Pharmaceutical Science, or related discipline

Herramientas

Process diagrams

SOPs documentation

Descripción del empleo

Coalesce Management Consulting is seeking a Manufacturing Operations Specialist to provide hands-on support for single-use systems within a GMP biopharma environment. You will coordinate change controls, assist with process documentation, and ensure equipment readiness on the manufacturing floor.

The role requires five years of relevant experience and a willingness to participate in a 24/7 on-call rotation.